Fmc - North Salisbury

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 44367 Based on observations, staff interview and record review, the facility’s administration and the Medical Director failed to ensure that enough supplies were available to provide care during an emergency evacuation. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency. Findings included: Review on 05/08/2024 of the facility’s policy entitled “Emergency Medication, Equipment and Supplies” page 1 revealed, “Emergency evacuation Box: An emergency box contains supplies primarily needed to emergently remove needles, cap catheters, and provide saline as needed for every licensed station once the patient is in a secure location.” On 05/08/2024 at 09:40 a.m., during inspection of the facility’s two evacuation boxes, the surveyors noted that the evacuation box did not contain enough supplies for every licensed station. The surveyor counted enough supplies for twenty stations. On the surveyors request , the Facility Administrator witnessed and agreed with the surveyors findings.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 44367 Based on observations of the clinical treatment area, the Clinical Nurse Manager and Medical Director failed to ensure that the clinical staff followed safe practices when handling infectious wastes. This failure created a potential risk of blood exposure and risk of harm to patients and staff in the unit. Staff: #6 and #12 Findings included: The Occupational Health and Safety Administration (OSHA): 29CFR1910.1030(d)(2)(xi)states: “All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. Carrying contaminated blood tubing, used needles, syringes and dialyzer from the patient’s station across the treatment floor to a biohazard box, or sharps container could result in unknown spattering of blood. 1. During observation of the clinical treatment area on 05/08/2024 at 09:24 a.m., Staff #6 walked dirty bloodlines from station D across occupied station C to discard in the biohazard trash bin. 2. During observation of the clinical treatment area on 12/13/2022, Staff #12 walked dirty bloodlines from station F across occupied station E to discard in the biohazard trash bin. The Facility Administrator was informed of the findings on 05/08/2024.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 44367 Based on record review, the Facility’s Administration and the Medical Director failed to assure that facility staff members received the appropriate education and training on infection control practices for hemodialysis as required. This failure placed patients, visitors, and staff at potential risk for exposure to bloodborne pathogens and infectious diseases. Staff: #5, #6 and #7 Findings include: According to the Occupational Safety and Health Administration (OSHA), dialysis staff must receive bloodborne pathogen training annually with personnel records reflecting staff having received appropriate infection control training. Furthermore, the Centers for Disease Control and Prevention (CDC) also states that they recommend infection control training initially on employment and annually. On 05/08/2024, during record review of the facility’s “ESRD Personnel File Review” form, the surveyor noted that 3 out 24 employees did not complete their annual infection control training. The Facility Administrator was given the opportunity to provide additional information; However, no additional information was provided. 1. Staff #5 last annual Infection control training was completed on 03/02/2023. 2. Staff #6 last annual infection control training was completed on 05/09/2022. 3. Staff #7 last annual infection control training was completed on 06/04/2021. The Facility Administrator was informed of the findings on 05/08/2024.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #8 and #11 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” According to the facility’s policy entitled, “Changing the Catheter Dressing Procedure” page 2 states, “2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds.” According to the facility’s policy “Initiation of Treatment Using a Central venous Catheter and Optiflux Single Use Ebeam Dialyzer” page 4 states, “Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) for 10-15 seconds and any time caps are removed, or bloodlines are disconnected (i.e. end of treatment or treatment interruption) to reduce risk of contamination.” 1. Observation of the clinical treatment area on 05/07/2024 at 09:20 a.m. revealed, during initiation of treatment at station E, Staff #8 cleaned catheter exit site for thirteen (13) seconds. 2. Observation of the clinical treatment area on 05/08/2024 at 09:39 a.m. revealed, during initiation of treatment at station N, Staff #11 scrubbed arterial and venous hubs for 9 seconds at the same time and cleaned the catheter exit site for 20 seconds. The Facility Administrator was informed of the findings on 05/07/2024 and 05/08/2024.”

“BACT OF H20-MEDICAL DIRECTOR RESPONSIBLE CFR(s): 494.40(a) 4.1.2 Bacteriology of water: med dir resp The facility medical director is responsible to ensure the manufacturer or supplier of a complete water treatment and distribution system demonstrates that the complete water treatment, storage, and distribution system is capable of meeting these requirements at the time of installation Following installation of a water treatment, storage, and distribution system, the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels. This Standard is not met as evidenced by: 44367 Based on review of the Reverse Osmosis (RO) water, dialysate and Hemodialysis (HD) machine culture logs, and interviews with the biomedical technician, the governing body and medical director failed to ensure that systems were continually monitored for bacteria colony forming units and endotoxins. This failure to provide oversight for the RO water, dialysate, and HD machine cultures placed the facility’s patients at risk of harm and potential exposure to infection. Findings included: Review on 05/07/2024 of the facility’s policy, “AAMI Chemical Analysis of Water and Dialysis” page 5 states, “Medical Director must review and sign each chemical analysis report obtained during the review period.” Review on 05/07/2024 of the facility’s monthly RO water, dialysate, HD machine culture reports and an interview with the Biomedical staff and the Facility Administrator on 05/07/2024 revealed the medical director did not sign and date (proof of acknowledging the culture collection results during the review period) reports from October 2023 and April 2024. The reports from October 2023, November 2023 and February 2024 did have a signature but did not have a date. The Biomedical Technician and the Facility Administrator both stated there have been challenges to get the cultures signed by the physician as required. The Facility Administrator and the Biomedical Technician corroborated the findings on 05/07/2024.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 44367 Based on observations of the clinical treatment area, the Facility Administrtaor and the Medical Director failed to ensure that the clinical staff followed safe practices when handling infectious wastes. This failure created a potential risk of blood exposure and risk of harm to patients and staff in the unit. Findings included: The Occupational Health and Safety Administration (OSHA): 29CFR1910.1030(d)(2)(xi)states: “All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. Carrying contaminated blood tubing, used needles, syringes and dialyzer from the patient’s station across the treatment floor to a biohazard box, or sharps container could result in unknown spattering of blood. A sharps container is a hard-plastic container that is used to safely dispose of hypodermic needles and other sharp medical instruments such as IV catheters and disposable scalpels. Sharps containers must be discarded when they are “three-quarters full”, according to the Food and Drug Administration, in order to prevent staff and patients from getting injured by a sharp object. Observation of the clinical treatment area on 4/21/2022 at 10:00 a.m. revealed, the sharps containers at stations #7 and #10 were greater than three-quarters (¾) full.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 44367 Based on observation and review of the facility’s policies and procedures, the facility’s administration failed to ensure that the facility provided and maintained a safe treatment environment for its patients by ensuring the facility conduct fire drills as required. This failure placed the patients and visitors at potential risk of harm. Findings: Review on 05/08/2024 of the facility’s policy “Comprehensive Emergency/Fire Drill and Evaluation” page 2 states, “A fire drill is required to be conducted quarterly. Fire drills are conducted to ensure that the facility’s staff and patients are prepared in the event of a fire.” During review of the emergency preparedness binder on 05/08/2024, it was noted that the facility conducted a fire drill on 07/26/2023 and then on 04/26/2024. The Facility Administrator was given the opportunity to provide additional documentation for proof of fire drills; however, no additional documentation was provided. The Facility Administrator corroborated that the facility did not conduct fire drills per policy.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44367 Based on observations, and a review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the facility provided an environment that is free of expired supplies. This failure placed the patients at potential risk of harm. Findings include: When medications and supplies are no longer needed, they should be disposed of promptly. Healthcare providers should remove expired medications and supplies as quickly as possible to help reduce the chances that others accidentally receive or intentionally misuse them. Inspection of the Peritoneal Dialysis (PD) area on 05/08/2024, revealed the following: 1. Room 1: One (1) nasal cannula lot number 41894 expired 03/01/2024 One (1) Disposable AV Fistula Needle Set lot number 2102010970, expired 04/07/2024. Two (2) Polylined Sterile Field lot number HX1510B01, expired 10/2018 2. Room 4: One (1) 0.9% Sodium Chlorine 100 ml bag lot number US013215, expired 03/2024. The PD Manager was informed of the findings on 05/08/2024.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44367 Based on review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were the same as what the patients received. Failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm, injury, and denied the patients their rights. Patients: #1, 4, 8 & 9. Findings included: The treatment flowsheet is the form used to record the patient’s care during dialysis. Recorded information includes the patient’s blood flow rates (BFR) and the dialysate flow rate (DFR), the patient’s blood pressure, administration of medications, visual observations of the patient and any patient complaints. This information may be hand written or computer generated. A review of nine (9) patients’ treatment flowsheets on 05/07/2024, revealed that four (4) of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. According to the facility’s policy “Nursing Supervision and Delegation”, page 5, The registered nurse must evaluate each patient preferably within an hour to : Review accuracy and completeness of treatment and patient data; Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed.” 1. On treatment date 05/04/2024, Patient #1’s BFR was prescribed for 450 ml/min. however, BFR was set at 400 ml/min from 05:53 a.m. to 09:00 a.m. There was no documentation found explaining why Patient #1’s BFR was not set on the dialysis machine as prescribed. 2. On treatment date 05/03/2024, Patient #4’s BFR was prescribed for 400 ml/min. however, BFR was set at 300 ml/min from 11:06 a.m. to 12:32 p.m. There was no documentation found explaining why Patient #4’s BFR was not set on the dialysis machine as prescribed. 3. On treatment date 03/02/2024, Patient #8’s BFR was prescribed for 400 ml/min. however, BFR was set at 350 ml/min from 11:32 a.m. to 2:35 p.m. There was no documentation found explaining why Patient #8’s BFR was not set on the dialysis machine as prescribed. 4. On treatment date 11/14/2023, Patient #9’s BFR was prescribed for 400 ml/min. however, BFR was set at 300 ml/min from 10:00 a.m. to 1:33 p.m. There was no documentation found explaining why Patient #9’s BFR was not set on the dialysis machine as prescribed. The Facility Administrator was informed of the findings on 05/04/2024.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 44367 Based on a review of personnel records, and interviews with the facility’s administration and staff, the facility’s administration failed to ensure applicable clinical personnel were up-to-date with required certifications and annual training. This failure placed patients at potential risk for harm. Staff: #3, #4 and #5 Findings include: Review on 05/08/2024 review of the facility’s personnel files revealed that 3 out of 24 staff members annual training was not completed annually. The Facility Administrator was given multiple opportunities to provide updated information. Documentation revealed the following: 1. Staff #3 Annual Clinical Skills and Validation and Exam was completed 04/25/2023. 2. Staff #4 Annual Clinical Skills and Validation and Exam was completed 07/20/2022. 3. Staff #5 Annual Clinical Skills and Validation and Exam was completed 03/03/2022. The Facility Administrator was informed of the findings on 05/08/2024.”